October 22, 2010

Many physicians find productive and rewarding careers in industry. Other physicians believe that sharing information about validated, regulated, and often under-utilized products through industry-sponsored lectureships or accredited continuing medical education (CME) programs is important to public health and contributes to better medical care. Those physicians and health care providers who collaborate with industry and provide these services come from a wide range of educational backgrounds and experiences.

There is no dispute that the “medical profession has suffered some serious self-inflicted wounds: high-profile physicians pocketing enormous “consulting” fees from drug companies or permitting drug companies to commandeer the content of their lectures; others accepting virtual payola from drug salesmen to tout their products.” However, these rare incidents should not underscore the overwhelming majority of partnerships between health care providers and industry is productive.

Despite the positive impact of this collaboration has, a recent book offers an unbalanced picture of contemporary American medicine. White Coat, Black Hat, written by Carl Elliott, is a one sided story about “how medicine has gone wrong, not in what there is to admire.”

Elliott, who is a non-practicing physician, uses his book as an attempt to humiliate physicians who choose industry careers or engage in constructive professional activities outside of direct patient care and conventional academic life. His book attempts to pigeonhole professionals into a narrow range of titles and responsibilities, and reflects a poor understanding about how knowledge of medicine and technology is generated and transferred. His cynical and gloomy ruminations will appeal to some but our dynamic health system has little patience for such anachronism.

A recent review of Elliott’s book by Sally Satel, a psychiatrist, resident scholar at the American Enterprise Institute, and a lecturer at Yale University School of Medicine, explains how Elliott, who is also a professor at the Center for Bioethics at the University of Minnesota, dispelled “any promise of even-handedness” in writing this book.

As Dr. Satel noted, Elliott thinks the current nature of physician-industry relationships “have constructed a medical system in which deception is often not just tolerated but rewarded.” To support such a claim, Elliott uses vivid stories about “lackey ghostwriters who pen journal articles under the names of cooperating physicians, and arrogant physicians who happily sell their reputations as paid spokesmen for Viagra and Vioxx.”

In doing so, White Coat, Black Hat “succeeds in highlighting the worst side of the physician-industry relationship,” even though he noted in an interview about the book that he didn’t like “being a self-righteous, finger-wagging, self-appointed expert trying to point out to the world what other people are doing wrong.”

Since Elliott thinks he does not have “any moral expertise more than anybody else,” then why did he write the book? Is he donating the proceeds to ensure that people without insurance can get healthcare? No.

The reality is, he wrote a one sided narrative so he could sell a book. If he had covered both sides of the story, readers would see that “academic medicine has made realprogress in addressing conflict of interest.” Moreover, within the past five years or so, as Dr. Satel noted, “virtually all the major interested bodies—the Food and Drug Administration, the Accreditation Council for Continuing Medical Education, PHRMA,theAmerican Medical Association , theInternational Committee of Medical Journal Editors—have issued robust standards to protect against conflicts of interest.”

As a result, Elliott’s book comes a few years too late, and “unfortunately keeps alive the impression that corruption, both subtle and overt, is rife,” when it is extremely rare. The “Wild West days of free-ranging drug salesmen, lavish gifts, and pharma-scripted talks are largely over.” Nevertheless, it is because of critics like Elliott that “young physicians or scientists are ridiculed if they even contemplate a career in private sector drug development.” These critics never consider how this will affect America’s future as the leader in medical and scientific progress and innovation, especially considering the majority of this progress comes from industry-physician collaboration.

As Dr. Satel noted, so what if “detailing does indeed tend to boost physicians’ prescribing of a given medication?” Why assume that this represents a “thank you” for the free lunch? And, worse, why assume that patients were harmed?

Instead, Dr. Satel acknowledges, “rather than having succumbed to the siren song of the Prozac mug, perhaps doctors altered their prescribing patterns in hopes that new products would help patients who are not responding well to the current regime or who suffer unacceptable side-effects.” For now, there is no data suggesting any harm to patients from working with industry because no studies have used clinical outcomes.

Accordingly, “it is one thing to scorn emblazoned mouse pads and other tchotchkes, but quite another to denounce academic-industry relationships,” which Elliott does. As Dr. Satel correctly noted, “these partnerships are vital drivers of medical innovation. The “bench to bedside” process starts with university investigators—among the best and the brightest—who develop and then patent novel molecules and other inventions.” These “fruitful public-private collaborations have produced dozens of life-saving therapies, including the vaccine for hepatitis B, beta interferon for multiple sclerosis, and Herceptin for breast cancer.”

Dr. Satel also clears up another controversy Elliott’s book tries to make surrounding industry funding of medical education for physicians, or Continuing Medical Education (CME). Critics such as Elliott make an issue with “whether company-sponsored lectures are skewed to favor the company’s drug.” However, as Dr. Satel asserts, “in major medical centers this is rarely the case given stringent policies whereby the sponsor has no input whatsoever into the content of the lecture or the selection of the expert.”

While there is always room for improvement, academic medical centers like the University of Michigan, who have decided to no longer take any money from drug and device makers to pay for coursework doctors, will cause “training to suffer.” Moreover, Dr. Satel noted, “such a move will be especially damaging to non-academic medical centers—which comprise the majority of hospitals– because they will not be able to afford the lectures on their own.”

In the end, what is problematic about Elliott’s book, like most critics of industry-physician collaboration, is that he does “not pursue policy options explicitly; he just strongly implies that the only solution is to sever all ties between physicians and the pharmaceutical industry.” As Dr. Satel notes, at what cost do we sever such ties? If, as Elliott claims, “American medicine relies so heavily on commercial interests to be its major source of intelligence about pharmacology and therapeutics, then the failure of the profession to educate itself is alarming indeed.”

Dr. Satel makes an important point that critics of collaboration often overlook: “economic gain is not the only potential corrupting influence within academic medicine. The intense quest for tenure, publication, promotion, federal grant money, editorships, and professional fame are famously compelling distractions from the best interests of patients and science.”

As a result, instead of focusing on ways to prohibit productive and important relationships, Dr. Satel recommends that “conflict of commercial interest should be treated the way we manage all conflicts of interest: focus on practices (e.g. failure to disclose commercial relationships); police and punish concrete wrongdoing; and tutor trainees in the complex realities of maintaining professional virtue in a world where innovation is so often commercially driven.

Comments

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1) From my personal experience as a practicing adult and child and adolescent psychiatrist, I attest that Dr. Satel's view of the benefit of pharm reps meeting with MD as beneficial is flawed. Up until 2004 I met with Drug reps and always used name brand psych drugs. For the last 6 years I have not seen any reps, and I predominantly used generics, especially lithium with as good or better results
2) Dr. Satel misses the point of the book : that the beneficence and fiduciary issues between health care provider and patient will always be under threat from countervailing demands on providers and researchers. For this reason every patient must ask and assess these issues before deciding to approve or reject a physician's recommendations. Carl Elliott did us a service - both provider and patient- in illustrating the myriad of ways these conflicts can occur
3) Dr. Satel should have indicated how her employment in the American Enterprise Institute might have influenced her review. For example, are Big Pharm Companies donors to the Institute?